IEC 60601-1-6
E477171
IEC 60601-1-6 is a collateral standard in the IEC 60601 series that specifies usability engineering requirements for medical electrical equipment and systems to help ensure safety and effectiveness in clinical use.
All labels observed (1)
| Label | Occurrences |
|---|---|
| IEC 60601-1-6 canonical | 3 |
How this entity was disambiguated
This entity first appeared as the object of triple T4780751 — resolving that mention is where its identity was fixed. The disambiguator weighed these candidate entities and picked the highlighted one (or “None”, minting a new entity). This is how homonymy is resolved: the same surface form can point to different entities.
NED1
Entity disambiguation (via context triple)
gpt-5-mini-2025-08-07
Target entity: IEC 60601-1-6 Context triple: [IEC 60601-1, isBasisFor, IEC 60601-1-6]
-
A.
IEC 60601-1
IEC 60601-1 is an international standard that specifies general safety and essential performance requirements for medical electrical equipment and systems.
-
B.
IEC 62591
IEC 62591 is an international standard that defines the WirelessHART industrial wireless communication protocol for process automation and control applications.
-
C.
IEC 61334
IEC 61334 is an international standard that defines protocols and requirements for low-speed power line communication used in utility and smart grid applications.
-
D.
IEEE Std 610.12-2010
IEEE Std 610.12-2010 is an updated IEEE standard that provides a formal glossary of terms and definitions used in software engineering.
-
E.
IEEE 11073 medical device communication standards
IEEE 11073 medical device communication standards are a family of international standards that define interoperable data exchange and integration between medical devices and healthcare information systems.
- F. None of above. chosen
- G. Unsure - the case is ambiguous/there is not enough information to decide.
NED2
Entity disambiguation (via description)
gpt-5-mini-2025-08-07
Target entity: IEC 60601-1-6 Target entity description: IEC 60601-1-6 is a collateral standard in the IEC 60601 series that specifies usability engineering requirements for medical electrical equipment and systems to help ensure safety and effectiveness in clinical use.
-
A.
IEC 60601-1
IEC 60601-1 is an international standard that specifies general safety and essential performance requirements for medical electrical equipment and systems.
-
B.
IEC 62591
IEC 62591 is an international standard that defines the WirelessHART industrial wireless communication protocol for process automation and control applications.
-
C.
IEC 61334
IEC 61334 is an international standard that defines protocols and requirements for low-speed power line communication used in utility and smart grid applications.
-
D.
IEEE Std 610.12-2010
IEEE Std 610.12-2010 is an updated IEEE standard that provides a formal glossary of terms and definitions used in software engineering.
-
E.
IEEE 11073 medical device communication standards
IEEE 11073 medical device communication standards are a family of international standards that define interoperable data exchange and integration between medical devices and healthcare information systems.
- F. None of above. chosen
Statements (44)
| Predicate | Object |
|---|---|
| instanceOf |
IEC standard
ⓘ
medical device usability standard ⓘ |
| aimsTo |
reduce risks associated with use of medical electrical equipment
ⓘ
reduce risks associated with use of medical electrical systems ⓘ |
| appliesTo |
medical electrical equipment
ⓘ
medical electrical systems ⓘ |
| focusesOn |
usability of medical electrical equipment
ⓘ
usability of medical electrical systems ⓘ |
| hasAbbreviation |
IEC
ⓘ
linked to:
International Electrotechnical Commission
|
| hasDomain |
clinical engineering
ⓘ
healthcare usability ⓘ medical technology ⓘ |
| hasGoal |
improvement of clinical effectiveness
ⓘ
improvement of patient safety ⓘ improvement of user interface design ⓘ reduction of use errors ⓘ |
| hasPurpose |
to help ensure effectiveness in clinical use
ⓘ
to help ensure safety in clinical use ⓘ |
| hasScope |
requirements for documentation of usability engineering
ⓘ
requirements for evaluation of usability ⓘ requirements for usability engineering process ⓘ |
| hasSubject | usability engineering ⓘ |
| hasType | collateral standard ⓘ |
| isCollateralTo | IEC 60601-1 ⓘ |
| isReferencedIn | medical device regulatory guidance in multiple jurisdictions ⓘ |
| isRelatedStandard | IEC 62366 ⓘ |
| isUsedBy |
medical device manufacturers
ⓘ
regulatory affairs professionals ⓘ usability engineers ⓘ |
| isUsedFor |
design of medical electrical equipment
ⓘ
development of medical electrical systems ⓘ validation of usability of medical devices ⓘ verification of usability engineering processes ⓘ |
| partOf |
IEC 60601 series
ⓘ
linked to:
IEC 60601
|
| publishedBy | International Electrotechnical Commission ⓘ |
| relatesTo |
human factors engineering
ⓘ
risk management for medical devices ⓘ user interface design ⓘ |
| requires |
systematic usability engineering process
ⓘ
usability engineering file ⓘ |
| supports |
demonstration of basic safety related to usability
ⓘ
demonstration of essential performance related to usability ⓘ |
| targets |
intended use environments of medical electrical equipment
ⓘ
intended users of medical electrical equipment ⓘ |
How these facts were elicited
The pipeline generated the facts above by prompting gpt-5.1 with this entity's name + description and the instruction below.
Instruction
You are a knowledge base construction expert. Given a subject entity and a description of it, return factual statements that you know for the subject as a JSON list of dictionaries(triples), where keys must be "subject", "predicate" and "object". The number of facts may be very high, between 25 to 50 or more, for very popular subjects. For less popular subjects, the number of facts can be very low, like 5 or 10. # Requirements - If you don't know the subject at all, return an empty list. - If the subject is not a named entity, return an empty list. - Include at least one triple where predicate is "instanceOf". - Do not get too wordy. - Separate several objects into multiple triples with one object.
Input
Subject: IEC 60601-1-6 Description of subject: IEC 60601-1-6 is a collateral standard in the IEC 60601 series that specifies usability engineering requirements for medical electrical equipment and systems to help ensure safety and effectiveness in clinical use.
Referenced by (3)
Full triples — surface form annotated when it differs from this entity's canonical label.